An interventional study of Indocyanine green (ICG) and Electromagnetic navigation bronchoscopy in Lung Cancer, sponsored by Jiayuan Sun. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-02.
Sponsored by Jiayuan Sun · Not applicable, Interventional, and Supportive care
The purpose of the study is to evaluate the efficacy and safety of transbronchial ICG and percutaneous hook-wire assisted Video-assisted thoracoscopic sublobar resection. In the control group, CT-guided percutaneous hook-wire preoperative localization will be used for surgical resection; In the experimental group, electromagnetic navigation bronchoscopy guided transbronchial ICG injection will be performed for localization before VATS.
This is a single-center, prospective, randomized trial initiated by the investigator. Subjects with pulmonary nodules who will undergo Video-assisted thoracoscopic sublobar resection will be randomly divided into two groups. In the experimental group, before the VATS operation, transbronchial ICG injection will be guided by electromagnetic navigation bronchoscopy to locate the nodule. In the control group, the subject will undergo CT guided hook-wire placement for nodule localization before VATS. The study is expected to enroll 188 patients. Finally, the effectiveness and safety of the two methods will be compared.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's planned enrollment of 188 is above the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Jiayuan Sun is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The nodule will be located preoperatively by ENB-Guided bronchoscopic ICG injection; During the VATS operation, a near-infrared fluorescence thoracoscopy will be used to identify ICG distribution in the visceral pleura to guide an accurate surgical resection.
Device: Indocyanine green (ICG) · Device: Electromagnetic navigation bronchoscopy
The nodule will be located preoperatively by percutaneous placement of hook wire; During the VATS operation, the resection scope is determined by the location relationship between hook wire and the nodule under CT scan.
Device: Hook wire
Indocyanine green (ICG) was diluted with saline to 0.5mg/mL, and injected 0.6mL/site.
Electromagnetic navigation bronchoscopy (ENB) allows physicians to access peripheral lung nodules with high accuracy and provides a working channel for ICG injection.
Hook wire is a puncture locating needle with a hook head that is about 1 cm in length and 30 cm metal wire behind. Through the puncture path planned based on CT scan, hook wire puncture percutaneously into the chest cavity to reach the lesion for localization.
Success rate of the localization procedure
Calculated as follows: (number of successful targeting procedures/number of all localization procedures)\*100
Time frame: On the 1 day of localization operation
Success rate of the effective localization
Calculated as follows: \[(number of successful targeting procedures-number of dislodgements or unrecognized in the operative field)/number of all localization procedures\]\*100
Time frame: On the 1 day of VATS operation
Success rate of VATS sublobar resection
Calculated as follows: (number of successful VATS procedures/number of all localization procedures)\*100
Time frame: On the 1 day of VATS completion
Safety endpoint
Complication rate of two localization methods, including pneumothorax, hemorrhage, etc.
Time frame: On the 1 day of VATS operation
Localization time
The localization time of the control group was defined as the time from the first CT scan which set the path for percutaneous puncture, to the last CT scan which confirmed the hook wire located at the expected site. The localization time of the experimental group was defined as the time from the insertion of bronchoscope to the glottis, to the withdrawal of bronchoscope from the glottis after ICG injection.
Time frame: On the 1 day of localization operation
Operation time of VATS sublobar resection
The operation time is defined as the time from the start of the skin incision to the completion of the suture of the skin.
Time frame: On the 1 day of VATS completion
This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jiayuan Sun